FDA Registration Active 🇩🇪 Germany

Carl Zeiss Meditec AG (Jena)

Reg #: 9615030 · FEI: 3001362763 · Expires 2026
Products
22
Proprietary Names
77
Establishment Types
5
Classifications
22

Registration Details

Registration Name
Carl Zeiss Meditec AG (Jena)
Registration Number
9615030
FEI Number
3001362763
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Carl-Zeiss-Promenade 10
City
Jena Thuringia
Country
DE

Regulatory Submissions

510(k) Number
K150467
PMA Number
P060004

Owner / Operator

Firm Name
Carl Zeiss Meditec AG (Jena)
Operator Number
9053564
Address
Goeschwitzer Strasse 51-52
City
Jena
State
Thuringia
Postal Code
07745
Country
DE
Correspondent
Carl ZEISS Meditec AG (Jena)

US Agent

Business Name
CARL ZEISS MEDITEC, INC.
Contact Name
Paul Swift
Address
5300 Central Pkwy
City
Dublin
State
CA
ZIP
94568
Country
US
Phone
817 9258507

Products

Device Name Product Code
System, Image Management, Ophthalmic NFJ
Instrument, Measuring, Lens, Ac-Powered HLM
Keratome, Ac-Powered HNO
Powered Laser Surgical Instrument GEX
Camera, Ophthalmic, Ac-Powered HKI
Biomicroscope, Slit-Lamp, Ac-Powered HJO
Laser, Ophthalmic HQF
Refractometer, Ophthalmic HKO
Topographer, Corneal, Ac-Powered MMQ
Device, Storage, Images, Ophthalmic NFF
Device, Communications, Images, Ophthalmic NFG
Tomography, Optical Coherence OBO
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
Microscope, Surgical EPT
Marker, Ocular HMR
Table, Instrument, Powered, Ophthalmic HRJ
Chart, Visual Acuity HOX
Refractor, Manual, Non-Powered, Including Phoropter HKN
Excimer Laser System LZS
Medical Device Data System OUG
Tonometer, Ac-Powered HKX
Ophthalmoscope, Battery-Powered HLJ

Proprietary Names

Retina Workplace VISULENS 500 VISULENS 550 Model 350, 355, 360 Humphrey Lens Analyzer Series VisuMax (HORUS) LASER KERATOME VISUCAM Pro NM FAF VISUCAM 224 VISUCAM 524 VISUCAM NM/FA FAF VISUCAM NM/FA VISUCAM ProNM ZEISS Slit Lamp SL 115 ZEISS Slit Lamp SL 120 ZEISS Slit Lamp HSO 10 ZEISS 20 SL Slit Lamp and Mechanical Micromanipulator VISULAS Trion Laser System with the VITE Option VISUREF 150 WASCA Analyzer VISUREF 100 (URK-800) Visulas YAG II Plus Ophthalmic Laser Ophthalmic ZEISS VISULAS Argon Laser VISULAS YAG III i.Profiler Plus ATLAS 500 IOLMaster 500 VISUPAC 481 FF450 Plus VISUPAC System IOL Master 700 CIRRUS photo Models 600 and 800 IOLMASTER 500 VISUCAM C Digital Camera IOLMASTER 500 with Option Reference Image IOLMASTER 500 with Reference Image mode Zeiss Cataract Suite Markerless SL 115, SL 120, SL cam 5 Digital Imaging Power Table Model AV 100 Power Table Model AV 220 Power Table Model HFA 230 Universal instrument table IT 760 Universal instrument table IT 760W.i Universal instrument table IT 1060.i Universal instrument table IT 1060 Universal instrument table IT 760.i Universal instrument table IT 760 W Power Table Model HFA 120 Power Table Model AV 120 Power Table Model HPT 120 Power Table Model CV-120 Power Table Model AV 240 Power Table Model CV-230 Power Table Model Stratus OCT ZEISS VISULAS YAG II Laser VISUSCREEN 100/500 VISULAS 532s Laser System with the VITE Option VisuScout 100 VISUPHOR 500 VISULAS Trion MEL 80 EXCIMER LASER SYSTEM MEL 90 Zeiss 30 SL-L Zeiss Slit Lamp SL 130 TRENION 3D HD MEDIALINK 100 EDIS / IDIS VISUConnect500 VISUHEALTH VERACITY surgical SL Imaging Solution SL 800 Sl 200 IOL Master VISUPLAN 500 Indirect Ophthalmoscope CIRRUS Photo Models 600 and 800 VISULAS 532s

Establishment Types

Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Foreign Private Label Distributor Repack or Relabel Medical Device